Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Pontifícia Universidade Católica do Paraná
Sponsor:
Collaborators:
Pontifícia Universidade Católica do Paraná
Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
Hospital Marcelino Champagnat, Paraná, Brasil
Fundação Araucária, Paraná, Brasil
Information provided by (Responsible Party):
Paulo Brofman, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01895413
First received: July 1, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.


Condition Intervention Phase
Osteoarthritis
Procedure: Bone marrow aspiration
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow-derived Mesenchymal Stem Cells Used in the Treatment of Articular Cartilage Injury

Resource links provided by NLM:


Further study details as provided by Pontifícia Universidade Católica do Paraná:

Primary Outcome Measures:
  • Change in WOMAC (Western Ontário and MacMaster Universities)score [ Time Frame: 3 months, 6 months, 9 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in cartilage thickness at 6 months by MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knee pain relief (WOMAC and Lequesne scores) [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stem cells
Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells
Procedure: Bone marrow aspiration
Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy

Detailed Description:

Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with mild to moderate osteoarthritis (visual analogue scale)
  • History of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage

Exclusion Criteria:

  • Any past history of neoplasia and primary hematological disease
  • Autoimmune disease or the medical history
  • Systemic bone or cartilage disorders
  • Acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
  • Co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy
  • Evidence of infection or fractures in or around the joint
  • Contraindication to bone marrow aspiration
  • Deviation from the axial axis (varus or valgus) greater than 12 degrees.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895413

Contacts
Contact: Paulo Brofman, PhD +55 41 3271 2219 paulo.brofman@pucpr.br
Contact: Alexandra Senegaglia, PhD +55 41 3271 2219 alexandra.senegaglia@pucpr.br

Locations
Brazil
Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná Recruiting
Curitiba, Paraná, Brazil, 80215-901
Contact: Alexandra Senegaglia, PhD    +55 41 32712219    alexandra.senegaglia@pucpr.br   
Principal Investigator: Paulo Brofman, PhD         
Sub-Investigator: Alexandra Senegaglia, PhD         
Sub-Investigator: Carmen Rebelatto, PhD         
Sub-Investigator: Danielle Malheiros, PhD         
Sub-Investigator: Debora Daga, MSc         
Principal Investigator: Alcy Vilas Boas Jr, PhD         
Sub-Investigator: Tamara Borgonovo, MSc         
Sub-Investigator: Danielle Jackowski, MSc         
Sub-Investigator: Gisele Sonda, MSc         
Sub-Investigator: Leticia Fracaro, MSc         
Sub-Investigator: Daniela Bocassanta, MSc         
Sponsors and Collaborators
Paulo Brofman
Pontifícia Universidade Católica do Paraná
Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil
Hospital Marcelino Champagnat, Paraná, Brasil
Fundação Araucária, Paraná, Brasil
Investigators
Principal Investigator: Paulo Brofman, PhD Pontifícia Universidade Católica do Paraná
  More Information

No publications provided

Responsible Party: Paulo Brofman, Dr, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier: NCT01895413     History of Changes
Other Study ID Numbers: CTM_LESÃO ARTICULAR-461/2010, CTM_LESÃO ARTICULAR-461/2010
Study First Received: July 1, 2013
Last Updated: July 10, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health

Keywords provided by Pontifícia Universidade Católica do Paraná:
Cartilage injury
Osteoarthritis
Mesenchymal stem cells

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014